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临床试验/NCT01681654
NCT01681654已完成不适用

Exercise and Nutrition for Head and Neck Cancer Patients: A Patient Oriented, Clinic-Supported Randomized Controlled Trial

University of Calgary2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Change from Baseline in Body Composition

研究概览

简要总结

Research on physical activity and nutrition interventions aimed at positively impacting symptom management, treatment-related recovery and quality of life has largely excluded head and neck cancer populations. This translates into a lack of clinical programming available for these patient populations. Head and neck cancer patients deal with severe weight loss, with upwards of 70% attributed to lean muscle wasting, leading to extended recovery times, decreased quality of life (QoL), and impaired physical functioning. To date, interventions to address body composition issues have focused solely on diet, despite findings that nutritional therapy alone is insufficient to mitigate changes. A combined physical activity and nutrition intervention, that also incorporates important educational components known to positively impact behaviour change, is warranted for this population. Pilot work suggests that there is large patient demand and clinic support from the health care professionals for a comprehensive program. Therefore, the purpose of the present study is to examine the impact of timing of a 12-week PA and nutrition intervention (either during or following treatment) for HN cancer patients on body composition, recovery, serum inflammatory markers and quality of life. In addition, the investigators will examine the impact of a 12-week maintenance program, delivered immediately following the intervention, on adherence, patient-reported outcomes (i.e., management of both physical and psychosocial treatment-related symptoms and side-effects), as well as return to work. The investigators hypothesize that (1) patients who are randomized to the intervention at treatment start will experience improved symptom management and decreased lean body composition changes, directly improving recovery and QoL; (2) patients who receive a maintenance support program will have better long-term adherence and therefore superior treatment-related symptom management, physical and psychosocial functioning; and (3) return to work indices will improve and healthcare utilization costs will be lower in the participants who receive the immediate intervention (vs. delayed) as well as in those who receive the maintenance program (vs. no maintenance). This research will facilitate advancements in patient wellness, survivorship, and autonomy, and carve the path for a physical activity and wellness education model that can be implemented in other cancer centers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Over 18 Years of Age
  • •Has received a diagnosis of nasopharyngeal, oropharyngeal or hypopharyngeal cancer
  • •Will receive radiation as part of treatment plan
  • •Able to walk without assistance
  • •Received clearance for exercise from treating oncologist
  • •Lives in Calgary, Alberta area
  • •Can speak and write English
  • •Is interested in participating in the study

排除标准

  • 未提供

研究组 & 干预措施

Immediate Lifestyle Intervention - Maintenance Program

Experimental

Patients will receive a 12-week lifestyle program during treatment. Patients will also receive maintenance support following the 12-week program.

干预措施: Lifestyle Intervention (Behavioral)

Immediate Lifestyle Intervention - Maintenance Program

Experimental

Patients will receive a 12-week lifestyle program during treatment. Patients will also receive maintenance support following the 12-week program.

干预措施: Maintenance Intervention (Behavioral)

Immediate Lifestyle Intervention - No Maintenance Program

Experimental

Patients will begin the 12-week lifestyle intervention during treatment. Patients will not receive a maintenance support following the 12-week intervention.

干预措施: Lifestyle Intervention (Behavioral)

Delayed Lifestyle Intervention - Maintenance Program

Experimental

Patients will receive a 12-week lifestyle intervention program following treatment (12 weeks after diagnosis). Patients will then receive maintenance support following the 12-week program.

干预措施: Lifestyle Intervention (Behavioral)

Delayed Lifestyle Intervention - Maintenance Program

Experimental

Patients will receive a 12-week lifestyle intervention program following treatment (12 weeks after diagnosis). Patients will then receive maintenance support following the 12-week program.

干预措施: Maintenance Intervention (Behavioral)

Delayed Lifestyle Intervention - No Maintenance Program

Experimental

Patients will receive a 12-week lifestyle intervention program following treatment completion (12 weeks following diagnosis). Patients will not receive maintenance support following the 12-week program.

干预措施: Lifestyle Intervention (Behavioral)

结局指标

主要结局

Change from Baseline in Body Composition

时间窗: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis

DXA Scan will be used to assess body composition

次要结局

  • Quality of Life(At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis)
  • Physical Activity Behaviour(At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis)
  • Smoking History(At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis)
  • Depression(At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis)
  • Karnofsky Performance Score (KPS)(At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis)
  • Inflammatory Markers(At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis)
  • Cancer related Symptom Management(At baseline (diagnosis) and then 3, 6, 9, 12 months post diagnosis & every week before and after class during the 12 week intervention)
  • Diet Behaviour - 3 Day food record(At baseline (diagnosis) and 4 & 8 weeks, 3, 6, 9, 12 months post diagnosis.)
  • Diet Behaviour: PG-SGA(At baseline (diagnosis), each week during radiation treatment (6.5 weeks in duration), and 3, 6, 9, 12 months post diagnosis)
  • Health related Fitness Measures - Resting Heart Rate(At baseline (diagnosis), and 3, 6, 9, 12 months post diagnosis.)
  • Health Related Fitness Outcome - Blood Pressure(At baseline (diagnosis), and 3, 6, 9, 12 months post diagnosis.)
  • Health Related Fitness Outcome - 6 minute walk test(At baseline (diagnosis), and 3, 6, 9, 12 months post diagnosis.)
  • Health Related Fitness Outcome - Grip Strength(At baseline (diagnosis) and 3, 6, 9, and 12 months post diagnosis.)
  • Health Related Fitness Outcome - Lower Body Strength(At baseline (diagnosis), and 3, 6, 9, and 12 months post diagnosis)
  • Health Related Fitness Outcome - Flexibility(At baseline (diagnosis) and 3, 6, 9, and 12 months post diagnosis)
  • Health Related Fitness Outcome - Balance(At baseline (diagnosis), and 3, 6, 9, and 12 months post diagnosis.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Nicole Culos-Reed

Associate Professor

University of Calgary

研究点 (2)

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